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Regulatory Affairs Officer
Role Overview
This role will be responsible for the preparation, distribution and control of registration documentation required for regulatory sumissions to high standards and within agreed timelines to ensure that marketing authorisations are obtained and maintained in line with the company’s requirements
The successful candidiate will work proactively with team members to ensure project needs are met compliantly within agreed timelines.
Company Information
Zenopa has partnered with a leading manufacturer of generic pharmaceutical products throughout the Uk and Europe.
Role Requirements
Responsibilities:
– Preparation of marketing authorisation application documentation to the highest possible standards, within the required timeframe, for submission to the regulatory authorities.
– Whole regulatory process, submissions for new launches.
– Working with a team towards a common goal with regulatory activites, this could be MHRA handling, submissions and dealing with variations.
Person Specifications
Ideal candidate background:
– Previous experience working within a regulatory environment.
– Previous experience within the pharmaceutical industry.
Package
Competitive Salary
Bonus
Private Healthcare
Locations
We aim to operate and maintain the following set of core values